The present invention is directed to a surgical scalpel handle and blade assembly system and method for requiring a surgical time out verification process be performed with actuator knobs on a scalpel handle prior to performing surgery when using a scalpel handle.
Physicians and surgeons use a scalpel handle to attach to a blade to excise human tissue for a variety of purposes.
Wrong site surgery can be disastrous psychologically for the patient, at the least, and result in death at its worst. Wrong site surgery by surgeons is common and a felt to be significantly underreported because of confidential data, embarrassment and legal liability. There is zero tolerance amongst patients and surgeons for wrong site, wrong person, and wrong procedure surgery errors. Yet, it is still projected to occur thousands of times each year. Wrong site surgery may have minimal health consequences in patients undergoing minor skin surgery but can be disastrous in those undergoing less minor surgery. Regardless of the level of surgery, for the patient, wrong site surgery is distressing and frightening. Wrong site surgery including wrong person surgery occurs not only in the operating room but also in a physician's office or surgery center. In fact, the Joint Commission on the Accreditation of Health Care Organizations instituted a Universal Protocol that requires a “time out” taken by the surgeon prior to performing surgery to confirm the location and the patient for the planned surgery prior to performing the surgery.
Taking a “time-out” before operative and other invasive procedures (Including at the patient bedside) is a requirement of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 2003 and the National Patient Safety Goals and a component of the new JCAHO Universal Protocol to prevent wrong site, wrong procedure, wrong person Surgery. This Universal Protocol was approved Jul. 18, 2003, by the JCAHO, and was implemented Jul. 1, 2004, for all JCAHO accredited Organizations that perform surgical or other types of invasive procedures. These recommendations are suggested for surgery taking place in any setting. Organizations and or their surgeons that fail to implement these recommendations risk a special Type 1 recommendation when surveyed by the JCAHO and more important risk the more serious possibly life threatening implications of wrong site or wrong patient surgery.
A “Time out” immediately before starting the procedure means prior to the start of any surgical or invasive procedure, the surgeon and staff conduct a final verification process, using active—not passive communication—to perform a “time out,” and to confirm the following:
1. Correct patient,
2. Confirm planned procedure and
3. Confirmed planned operative site.
Despite these requirements and recommendations, wrong site surgeries still happen each year because the “time out” is overlooked and often not performed as the surgeon or the surgical team still forgets or does not take the time to perform the “time out” verification process. In a study published in the Annals of Surgery in 2010, a significant difference was seen in the “time-out” not performed group of physicians as a root cause for wrong site (72%) versus wrong patient (0%) procedures and constituted 98.8% of all issues leading to wrong site occurrences. The conclusion of this study showed that main root causes leading to wrong patient procedures were related to lack of performing a “Time out” 72% of the time. 1 Strict adherence to taking a “Time out” is required to promote a zero-tolerance for these preventable sentinel events as wrong site surgeries are one of the top causes for adverse sentinel events during surgery.
In the art, surgical scalpels with blades are well known. Also, several methods are provided in the art to ensure that the scalpel during all of pre-use, use and post use conditions is safe and does not cause accidental harm to the operator. In U.S. Pat. No. 2,735,176 discloses a surgical knife that is provided with a hollow handle which functions as a sheath for the blade that is extendable through sliding and retractable between a first cutting position and a second shielded position. Similarly, U.S. Pat. Nos. 3,905,101 and 3,906,626 disclose sheaths wherein the handle carrying the blade is slideable from a first protective position to a second cutting position. In U.S. Pat. No. 6,757,977 discloses a disposable surgical safety scalpel with a retractable blade inside a hollow handle with a novel locking and unlocking arrangement that enables easy and safe use in various conditions. In U.S. Pat. No. 7,153,317 and U.S. Pat. No. 6,629,985 discloses a disposable guarded surgical with a handle and blade fixed to it and a slideable mounted guard and a surgical scalpel with retractable guard, respectively. These solutions are addressing the problem of accidental injury to the operator when handling a scalpel.
But none of these solutions address the problem of a surgeon using a scalpel before performing a surgical time-out verification process and none of these solutions address the issues of wrong site surgeries or wrong patient surgeries when a surgeon uses the scalpel. All of these systems have the same disadvantage in that they do not require the surgeon to perform action on the scalpel handle as part of the surgical time out process in order to release a surgical blade holder and ready the scalpel for surgery. Further none of these solutions use the scalpel as an interactive messaging tool with a novel knob sliding mechanism and changing visual indices through windows in scalpel handle to reflect and alert surgeon that scalpel has changed from “stop” to “go” status prior to performing surgery and confirm that he and his surgical team has performed the required surgical time out verification process. Picking up the scalpel by the surgeon is the very last step before cutting the patient's skin and as such is the most appropriate time to conduct the surgical time out. Using a surgical time out verification process method requiring a non passive action by the surgeon and the surgical team through the use of the scalpel handle can help remove the “impulsivity” associated with a surgeon's attitude, overwhelming schedule and obligations, and rush to meet time OR schedule demands and volume requirements.
Accordingly, a methodology which overcomes the shortcomings of prior art is desired.